ID

23028

Beskrivning

NCT00340080 / VIIV-CNA106030 https://clinicaltrials.gov/ct2/show/NCT00340080 A phase IV, randomised, multicentre, double-blind, study to evaluate the clinical utility of prospective genetic screening (HLA-B*5701) for susceptibility to abacavir hypersensitivity Assessment: Day 1 (Cohort Study) Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV

Länk

https://clinicaltrials.gov/ct2/show/NCT00340080

Nyckelord

Versioner (1)
  1. 2017-06-20 2017-06-20 -
Uppladdad den

20 juni 2017

DOI

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Licens

Creative Commons BY 4.0
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Genetic Screening For HLA-B*5701 n Patients with HIV Day 1 NCT00340080

Engelsk

Genetic Screening For HLA-B*5701 Day 1 NCT00340080

1 Formulär  
Day 1
Beskrivning

Day 1

Alias
UMLS CUI-1
C1516637
UMLS CUI-2
C0009247
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Is subject going to be followed prospectively in the cohort sub-study of HLA-B*5701 positive subjects?
Beskrivning

cohort sub-study

Datatyp

text

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0009247
Has the subject previously received and permanently stopped antiretroviral therapy prior to Day 1?
Beskrivning

If Yes, record each medication on a separate line using Trade Names where possible.

Datatyp

text

Alias
UMLS CUI [1]
C1963724
Drug Name (Trade name preferred)
Beskrivning

If Yes, record each medication on a separate line using Trade Names where possible.

Datatyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C1963724
Start Date
Beskrivning

If Yes, record each medication on a separate line using Trade Names where possible.

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1963724
Stop Date
Beskrivning

If Yes, record each medication on a separate line using Trade Names where possible.

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1963724
Ongoing Medication?
Beskrivning

If Yes, record each medication on a separate line using Trade Names where possible.

Datatyp

text

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C1963724
Vital signs: Blood pressure systolic
Beskrivning

Blood pressure systolic

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Vital signs: Blood pressure diastolic
Beskrivning

Blood pressure diastolic

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Vital signs: Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/minute
Alias
UMLS CUI [1]
C0018810
beats/minute
Vital signs: Temperature
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0005903
°C
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Similar models

Genetic Screening For HLA-B*5701 Day 1 NCT00340080

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Day 1
C1516637 (UMLS CUI-1)
C0009247 (UMLS CUI-2)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Is subject going to be followed prospectively in the cohort sub-study of HLA-B*5701 positive subjects?
text
C1516637 (UMLS CUI [1,1])
C0009247 (UMLS CUI [1,2])
Eligibility Question
Code List
Is subject going to be followed prospectively in the cohort sub-study of HLA-B*5701 positive subjects?
CL Item
Yes (Y)
CL Item
No (N)
Item
Has the subject previously received and permanently stopped antiretroviral therapy prior to Day 1?
text
C1963724 (UMLS CUI [1])
Eligibility Question
Code List
Has the subject previously received and permanently stopped antiretroviral therapy prior to Day 1?
CL Item
Yes (Y)
CL Item
No (N)
Drug Name
Item
Drug Name (Trade name preferred)
text
C2360065 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
Eligibility Question
Code List
Ongoing Medication?
CL Item
Yes (Y)
CL Item
No (N)
Blood pressure systolic
Item
Vital signs: Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic
Item
Vital signs: Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Vital signs: Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Vital signs: Temperature
float
C0005903 (UMLS CUI [1])
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